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The Cepheid Xpert®Respiratory Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Influenza A (H1N1) virus, Influenza A (H3N2) virus, Influenza B virus and Respiratory Syncytial Virus A performed with the Cepheid Xpert® Xpress Flu/RSV assay on the GeneXpert® Instrument System. The controls comprise cultured and inactivated Influenza A (H1N1) virus, Influenza A (H3N2) virus, Influenza B virus and Respiratory Syncytial Virus A as the positive control and Coxsackie virus B1 as the negative control.

The Cepheid Xpert®Respiratory Control Panel is not intended to replace manufacturer controls provided with the device.

The Cepheid Xpert® Respiratory Control Panel is used to monitor RNA extraction, amplification of the Cepheid Xpert® Xpress Flu/RSV assay. The Cepheid Xpert® Respiratory Control Panel contains cultured viruses inactivated by chemical or radiological treatments. Each Cepheid Xpert® Respiratory Control Panel consists of 6 individually packaged positive control swabs and 6 individually wrapped negative control swabs. Each positive control swab contains Influenza A (H1N1) virus, Influenza A (H3N2) virus, Influenza B virus and Respiratory syncytial virus A. Each negative control swab contains Coxsackie B1 virus. Each swab is individually wrapped with a desiccant in a heat-sealed foil pouch.

The acceptance criteria and study proving the device meets them are described below for the Cepheid Xpert® Respiratory Control Panel.

1. Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the Cepheid Xpert® Respiratory Control Panel, as demonstrated by the provided data, is 100% agreement between the expected and observed results for both positive and negative analytes.

It's important to note that the acceptance criteria are inferred from the demonstrated performance, as explicit numerical acceptance criteria for agreement percentages are not directly stated but consistently met at 100%.

2. Sample Size Used for the Test Set and Data Provenance

• Positive Controls: The test set included 90 individual tests for each positive analyte (Influenza A (H1N1), Influenza A (H3N2), Influenza B, and Respiratory Syncytial Virus A), resulting in a total of 360 positive control tests. This was broken down into 30 tests per analyte at each of the three sites.
• Negative Controls: The test set included 91 individual tests for the negative analyte (Coxsackievirus B1). This was broken down into 30 tests at Site 1, 30 tests at Site 2, and 31 tests at Site 3.
• Data Provenance: The study was conducted from three different production lots, at three different sites, using three different GeneXpert® Instrument Systems, and involved six different users. This suggests a prospective, multi-site study design intended to demonstrate real-world performance. The country of origin is not explicitly stated, but the applicant (Microbiologics, Inc.) is based in the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document describes the performance of an assayed quality control material for clinical microbiology assays. For such devices, the "ground truth" is inherent to the known composition of the control material (i.e., presence or absence of specific inactivated viruses). Therefore, no human experts or their qualifications are mentioned for establishing the ground truth of the control panel itself, as it's a manufactured standard. The "ground truth" is defined by the components of the control panel.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1 or 3+1) are typically used when there is ambiguity or disagreement in human interpretation of results, often in image analysis or diagnostic readings. For a quality control material like the Cepheid Xpert® Respiratory Control Panel, the result is an objective output from the GeneXpert® Instrument System (e.g., positive or negative for a specific virus). Therefore, an adjudication method for the test set is not applicable and not mentioned in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human reader performance, which is not relevant for an assayed quality control material designed to objectively monitor instrument performance rather than assist human interpretation of diagnostic images or clinical cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Yes, the study described is essentially a standalone performance evaluation of the quality control material itself when processed by the GeneXpert® Instrument System. The purpose is to verify that the control panel consistently yields the expected objective results when run through the assay, demonstrating its suitability for monitoring the RNA extraction, amplification, and detection stages of the assay. While humans operate the system and record results, the performance being assessed is that of the QC material and the GeneXpert system, without human "interpretation" of the QC result itself beyond confirming the expected positive/negative output.

7. The Type of Ground Truth Used

The ground truth used is the known composition of the manufactured control panel.

• For positive controls, the ground truth is the confirmed presence of specific inactivated viruses (Influenza A (H1N1), Influenza A (H3N2), Influenza B, and Respiratory Syncytial Virus A) at concentrations expected to be detected by the Cepheid Xpert® Xpress Flu/RSV assay.
• For the negative control, the ground truth is the confirmed presence of a non-target virus (Coxsackie B1) that should not be detected by the Cepheid Xpert® Xpress Flu/RSV assay.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" because this device is a quality control material, not a machine learning algorithm that requires training data. Its performance is evaluated based on its ability to produce expected results when tested, not by learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

As mentioned above, there is no training set for this type of device. The ground truth for the performance evaluation (test set) is intrinsically defined by the known biological composition and manufacturing specifications of the control panel itself.

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The Cepheid Xpert® SA Nasal Complete Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicilin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) performed with the Cepheid Xpert® SA Nasal Complete Assay on the GeneXpert® Dx System. The controls comprise cultured and inactivated Methicillin-Resistant Staphylococcus aureus as the positive control 1: Staphylococcus aureus as the positive control 2; Staphylococcus epidermidis as the negative control.

The Cepheid Xpert® SA Nasal Complete Control Panel is not intended to replace manufacturer controls provided with the Cepheid Xpert® SA Nasal Complete Assay.

The Cepheid Xpert® SA Nasal Complete Control Panel is used to monitor the DNA extraction, amplification and detection processes of the Cepheid Xpert® SA Nasal Complete Assay. The Cepheid Xpert® SA Nasal Complete Control Panel contains cultured microorqanisms inactivated by heat treatments. Each Cepheid Xpert® SA Nasal Complete Control Panel consists of 6 individually packaged Methicillin-Resistant Staphylococcus aureus (MRSA) positive control swabs (positive control 1): 6 individually wrapped Staphylococcus aureus (MSSA) positive controls swabs (positive control 2); and 6 individually wrapped negative control swabs. Each positive control 1 swab contains MRSA at a target level that is designed to provide reproducible performance above the limit of detection for each of the genes targeted by the Cepheid Xpert® SA Nasal Complete Assay: Staphylococcal protein A gene spa (SPA), methicillin resistance gene mecA (mec), and the Staphylococcal cassette chromosome (SCC). Each positive control 2 swab contains MSSA at a target level designed to provide reproducible performance above the limit of detection of the spa gene target of the Cepheid Xpert® SA Nasal Complete Assay. Each negative control swab contains Staphylococcus epidermidis (MSSE) which is methicillin susceptible and not detected by the Cepheid Xpert® SA Nasal Complete Assay. Each swab is individually wrapped with a desiccant in a heat-sealed foil pouch.

The provided document is a 510(k) summary for a medical device called the "Cepheid Xpert SA Nasal Complete Control Panel." This device is an assayed quality control material for clinical microbiology assays. It is not an AI/ML-driven device, diagnostic algorithm, or imaging device, but rather a quality control panel used in laboratory testing.

Therefore, many of the typical acceptance criteria and study aspects you've listed, which are relevant to AI/ML or imaging diagnostics (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth sources like pathology, training set size, etc.), do not apply to this type of medical device.

This document describes a performance study to demonstrate the precision and reproducibility of the quality control panel itself. The acceptance criteria relate to the ability of the control panel to consistently produce the expected results when tested with the target assay.

Here's an attempt to extract and reframe the information based on the document, while acknowledging that many of your requested points are not applicable:

Device: Cepheid Xpert® SA Nasal Complete Control Panel
Device Type: Assayed Quality Control Material for Clinical Microbiology Assays

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the format of pass/fail thresholds for a given metric. However, the study aims to demonstrate 100% agreement with expected results for positive and negative controls. The presented performance data shows this agreement was achieved.

Here's the performance data that implicitly represents the desired outcome (100% correct results):

An additional table for quantitative performance (Mean Ct and %CV) is provided for the positive controls and sample processing control, demonstrating reproducibility of the cycle threshold values across sites:

2. Sample size used for the test set and the data provenance

• Test Sample Size:
  • For each of the three types of controls (MRSA positive, MSSA positive, negative), there were 90 tests performed in total.
  • This was derived from: 3 testing locations x 2 operators/location x 3 lots x (minimum of) 3 tests/lot/operator/day over 5 days (totaling 30 tests per control type per site before accounting for specific retests). The summary table shows 30 tests per site, so 3 sites * 30 tests/site = 90 tests.
• Data Provenance: The document implies the data was collected prospectively as part of a performance study to support the 510(k) submission. Geographic origin is not specified but would typically be within the country of the applicant (USA, based on the address).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable: For a quality control material, the "ground truth" is inherent to the known composition of the control and the expected output of the assay it monitors (e.g., a positive control should be positive for specific targets). There is no "expert adjudication" or "radiologist experience" involved in establishing this kind of ground truth. The expected results are defined by the analytical properties of the material.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable: As there's no subjective interpretation, no adjudication method is needed. The results are quantitative (Ct values) or qualitative (Positive/Negative) based on the instrument's reporting. The document mentions retesting "NO RESULT," "INVALID," or "ERROR" samples, which is a standard laboratory practice for troubleshooting, not an adjudication process.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable: This is a quality control material, not an AI/ML diagnostic system. No human readers or AI assistance are involved in interpreting its direct output.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable: This is not an algorithm. The "standalone" performance demonstrated is the ability of the control panel itself to reliably elicit the expected response from the GeneXpert Dx System.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Analytical Ground Truth: The ground truth is the known composition of the control panel (e.g., contains inactivated MRSA, contains inactivated MSSA, contains inactivated S. epidermidis) and the expected analytical response of the target assay (Cepheid Xpert SA Nasal Complete Assay). For instance, an MRSA positive control should result in detection of SPA, mec, and SCC genes.

8. The sample size for the training set

• Not Applicable: This device is a quality control material, not an algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable: As above, there is no training set for this type of device. The characteristics of the control panel (contents, concentration) are established during its manufacturing and characterization process, not through a "ground truth establishment" phase for machine learning.

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The Cepheid Xpert® MRSA NxG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicillin-Resistant Staphylococus aureus performed with the Cepheid Xpert® MRSA NxG Assay on the GeneXpert® Instrument System. The controls comprise cultured and inactivated Methicillin-Resistant Staphylococcus aureus as the positive control and Staphylococcus epidermidis as the negative control.

The Cepheid Xpert® MRSA NxG Control Panel is not intended to replace manufacturer controls provided with the Cepheid Xpert® MRSA NxG Assay.

The Cepheid Xpert® MRSA NxG Control Panel is used to monitor the DNA extraction, amplification and detection processes of the Cepheid Xpert® MRSA NxG Assay. The Cepheid Xpert® MRSA NxG Control Panel contains cultured microorganisms inactivated by heat treatments. Each Cepheid Xpert® MRSA NxG Control Panel consists of 6 individually packaged positive control swabs and 6 individually wrapped negative control swabs. Each positive control swab contains cultured and inactivated Methicillin-Resistant Staphylococcus aureus (MRSA) at arget level that is designed to provide reproducible performance above the limit of detection for each of the genes targeted by the Cepheid Xpert® MRSA NxG Assay: methicillin resistance gene mecA (mec) and the Staphylococcal cassette chromosome (SCC). Each negative contains Staphylococcus epidermidis (MSSE) that is not detected by the Cepheid Xpert® MRSA NxG Assay. Each swab is individually wrapped with a desiccant in a heat-sealed foil pouch.

Here's a breakdown of the acceptance criteria and study details for the Cepheid Xpert® MRSA NxG Control Panel, based on the provided text:

Acceptance Criteria and Reported Device Performance

(Note: The provided text doesn't explicitly state the acceptance criteria as separate from the performance, but the 100% agreement achieved suggests this was the expected outcome for a control panel's precision and reproducibility study.)

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size:
     • For Positive Controls: 93 tests (32 at Site 1, 31 at Site 2, 30 at Site 3).
     • For Negative Controls: 92 tests (31 at Site 1, 31 at Site 2, 30 at Site 3).
   • Data Provenance: The study was conducted at three different testing locations (referred to as Site 1, Site 2, and Site 3). The document does not specify the country of origin, but it implies a prospective study since it describes "a precision and reproducibility study was conducted."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The concept of "ground truth" as established by experts (e.g., radiologists) is not applicable here. This is a study for a quality control material for a diagnostic assay, not an AI diagnostic device evaluating patient data. The "ground truth" for the control material is inherently defined by its composition (e.g., inactivated Methicillin-Resistant Staphylococcus aureus for the positive control, Staphylococcus epidermidis for the negative control) and the known expected results from the Cepheid Xpert® MRSA NxG Assay.

3. Adjudication method for the test set:

   • Not applicable. As this is a study for a quality control material, the results are objective (positive/negative detection) based on the performance of the assay with the control. There's no subjective interpretation requiring adjudication among experts. The study reports raw agreement percentages. Any "ERROR" responses were retested with a new control, indicating a procedural re-evaluation rather than expert adjudication of a result.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This type of study (MRMC for AI) is not applicable to a quality control panel. This product is a control material for an in-vitro diagnostic assay, not an AI-powered diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, in essence. The "device performance" refers to the performance of the control panel itself, which is then used by human operators with the GeneXpert® Instrument System and Cepheid Xpert® MRSA NxG Assay. While human operators are involved in running the test, the evaluation of the control material's performance against the assay's expected results is a standalone assessment of the control material's ability to consistently produce those results. This isn't an AI algorithm; rather, it's a quality control for an existing diagnostic system.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" for the control panel is based on its known composition and the expected analytical performance when run on the target assay. For the positive control, the ground truth is the presence of Methicillin-Resistant Staphylococcus aureus (mec, SCC) at a level detectable by the assay. For the negative control, the ground truth is the presence of Staphylococcus epidermidis which should not be detected by the target assay.

7. The sample size for the training set:

   • Not applicable. This study is for a quality control material, not a machine learning or AI algorithm that requires a training set. The "samples" used are the control materials themselves tested on the assay system.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set for an AI algorithm, this question is not relevant to the described device and study.

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The Cepheid Xpert® CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert® CT/NG assay on the GeneXpert® Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control.

The Cepheid Xpert® CT/NG Control Panel is not intended to replace manufacturer controls provided with the device.

The Cepheid Xpert® CT/NG Control Panel is used to monitor the extraction, amplification and detection of the Cepheid Xpert® CT/NG Assay. The Cepheid Xpert® CT/NG Control Panel contains authentic pathogens inactivated by radiological or temperature treatments. Each Cepheid Xpert® CT/NG Control Panel consists of 6 individually packaged positive control swabs and 6 individually wrapped negative control swabs. Each positive control swab contains Chlamydia trachomatis and Neisseria gonorrhoeae as well as preservatives and stabilizers. Each negative control swab contains human cells as well as preservatives and stabilizers. Each swab is individually wrapped with a desiccant in a heat-sealed foil pouch.

The provided text describes the acceptance criteria and performance data for the Cepheid Xpert® CT/NG Control Panel, which is an assayed quality control material for clinical microbiology assays. This is a diagnostic device, not an AI/ML-based device, so many of the requested criteria related to AI/ML studies (such as MRMC studies, training set details, or ground truth establishment by experts for imaging) are not applicable.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for this device appear to be 100% agreement with expected results for both positive and negative controls. The reported device performance met these criteria.

• C. trachomatis: 92/92 (100%)
• N. gonorrhoeae (NG2): 92/92 (100%)
• N. gonorrhoeae (NG4): 92/92 (100%)
• SPC: 92/92 (100%) |
  | Negative Controls: 100% agreement with expected negative results for all analytes (SAC, SPC) | 100% agreement for all analytes:
• SAC: 97/97 (100%)
• SPC: 97/97 (100%) |
  | Consistency in Ct values across sites and operators (implied by %CV data) | Mean Ct and %CV values were reported across sites, demonstrating consistency. (e.g., Overall Mean Ct for C. trachomatis 31.8 (3.8)). |

2. Sample size used for the test set and the data provenance

• Test Set Sample Size:
  • Positive Controls: 92 replicates were tested across three sites. (31 from Site 1, 31 from Site 2, 30 from Site 3, with some additional runs for re-tests).
  • Negative Controls: 97 replicates were tested across three sites. (33 from Site 1, 34 from Site 2, 30 from Site 3, with some additional runs for re-tests).
• Data Provenance: The data was generated prospectively through a multi-site evaluation. The document does not specify the country of origin of the testing sites, but given it's an FDA submission, it's highly likely to be within the US or under US regulatory guidelines.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is an in vitro diagnostic (IVD) device, specifically a quality control. The "ground truth" is inherent to the control material itself (i.e., the positive control contains the target microbes at a known concentration, and the negative control does not).

Therefore:

• Number of experts: Not applicable in the context of human interpretation for ground truth. The "ground truth" is established by the known composition of the control material (inactivated pathogens for positive, human cells only for negative).
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

Not applicable for an IVD quality control device. The results are quantitative (Ct values) and qualitative (positive/negative detection) based on the instrument's algorithm, not human interpretation requiring adjudication. Any "ERROR" or "INVALID" results were retested according to the Instructions for Use, which is a standard procedure for IVD testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an IVD quality control device, not an AI/ML imaging or diagnostic aid for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device evaluates the performance of the Cepheid Xpert® CT/NG assay and GeneXpert® Instrument System, which is an automated system. The performance data presented demonstrates the "standalone" or "algorithm only" performance of the control panel interacting with the assay/instrument system as intended, without human interpretation as a variable.

7. The type of ground truth used

The ground truth is based on the known composition of the control materials:

• Positive control: Contains cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae.
• Negative control: Contains human cells.

The "expected results" (positive or negative) are determined by these known compositions.

8. The sample size for the training set

Not applicable. This is a manufactured control material, not an AI/ML algorithm that requires a training set. Its development involves formulation and manufacturing processes, followed by validation and verification studies (which are described as the "performance data").

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the AI/ML sense for this type of device. The "ground truth" for the control material itself is established during its design and manufacturing by precisely controlling its components.

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The Cepheid Xpert® C. difficile/Epi Control Panel is intended for use as external assayed positive and negative quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Clostridioides (Clostridium) difficile performed with the Cepheid Xpert® C. difficile/Epi assay on the GeneXpert® Dx System. The controls comprise cultured and inactivated Clostridioides (Clostridium) difficile 027-NAP1-B1 as the positive control and Clostridium sordellii as the negative control.

The Cepheid Xpert® C. difficile/Epi Control Panel is not intended to replace manufacturer controls provided with the device.

The Cepheid Xpert® C. difficile/Epi Control Panel to monitor DNA extraction, amplification and detection of the Cepheid Xpert® C. difficile/Epi assay. The Cepheid Xpert® C. difficile/Epi Control Panel contains cultured microorqanisms inactivated by heat treatments. Each Cepheid Xpert® C. difficile/Epi Control Panel consists of 6 individually packaged positive control swabs and 6 individually wrapped negative control swabs. Each positive control swab contains cultured and inactivated Clostridioides difficile at a target level that is designed to provide reproducible performance above the limit of detection of the Cepheid Xpert® C. difficile/Epi assay. The positive control swab is expected to produce positive results for each of the genes targeted by the Cepheid Xpert® C. difficile/Epi assay: toxin B (tcdB), binary toxin (CDT) and the variant requlator gene, tcdC. Each negative control swab contains Clostridium sordelli. Each swab is individually wrapped with a desiccant in a heat-sealed foil pouch.

Here's an analysis of the provided text to fulfill your request regarding acceptance criteria and the study proving device performance:

Device Name: Cepheid Xpert C. difficile/Epi Control Panel

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a codified manner for a diagnostic accuracy study (e.g., target sensitivity, specificity). Instead, it presents the results of a precision and reproducibility study to demonstrate the performance of the control panel itself. The implicit acceptance criterion for a control panel is 100% agreement with the expected result (positive controls yield positive results, negative controls yield negative results).

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 91 positive control tests and 91 negative control tests.
  • For the positive control: 30 at Site 1, 31 at Site 2, 30 at Site 3.
  • For the negative control: 30 at Site 1, 31 at Site 2, 30 at Site 3.
• Data Provenance: The document does not specify the country of origin. The study was conducted as a "precision and reproducibility study," which is typically prospective, designed to evaluate product consistency.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This study evaluates a quality control panel, not a diagnostic device's ability to identify disease in patient samples. The "ground truth" for the test set is established by the known composition of the control panel itself (i.e., the positive control contains C. difficile, and the negative control contains C. sordellii). There are no human experts classifying images or results for ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is inherent in the design of the control panel. The performance is assessed against the expected molecular detection profile of the contained microorganisms.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a study for a quality control panel, not an AI-powered diagnostic device. No human readers or AI assistance are involved in interpreting the results beyond standard laboratory procedures for running the GeneXpert® Dx System.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The study inherently evaluates the "standalone" performance of the control panel in conjunction with the Cepheid Xpert® C. difficile/Epi assay on the GeneXpert® Dx System. The control panel is a reagent designed to monitor the assay's performance. The results (presence/absence of targets, Ct values) are generated directly by the GeneXpert system without further human interpretation beyond confirming the system's output.

7. The Type of Ground Truth Used

The ground truth is based on the known composition of the manufactured control materials. The positive control contains cultured and inactivated Clostridioides difficile, and the negative control contains Clostridium sordellii. The expected results are therefore known beforehand based on the microbial content.

8. The Sample Size for the Training Set

Not applicable. This device is a quality control panel, not an algorithm or AI system that requires a "training set." The study evaluated the performance of the manufactured controls.

9. How the Ground Truth for the Training Set Was Established

Not applicable (as described in point 8).

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The Cepheid Xpert® GBS LB Control Panel is intended for use as external assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert® GBS LB Assay on the GeneXpert® Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control.

The Cepheid Xpert® GBS LB Control Panel is not intended to replace manufacturer controls provided with the device.

The Cepheid Xpert® GBS LB Control Panel is used to monitor the extraction, amplification and detection of the Cepheid Xpert® GBS LB Assay. The Cepheid Xpert® GBS LB Control Panel contains authentic pathogens inactivated by temperature treatments. Each Cepheid Xpert® GBS LB Control Panel consists of 6 individually packaged positive control swabs and 6 individually wrapped negative control swabs. Each positive control swab contains Streptococcus agalactiae (Lancefield's Group B) as well as preservatives and stabilizers. Each negative control swab contains Lactobacillus as well as preservatives and stabilizers. Each swab is individually wrapped with a desiccant in a heat-sealed foil pouch.

Here's a breakdown of the acceptance criteria and study information for the Cepheid Xpert GBS LB Control Panel, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document describes a precision and reproducibility study to demonstrate device performance. The acceptance criteria are implicitly 100% agreement for both analytes (S. agalactiae and L. acidophilus) across different sites, operators, and lots.

Note: The reported device performance for both analytes shows 100% agreement, meeting the implicit acceptance criteria. One ERROR result was obtained for S. agalactiae at Site 1 but was retested with expected results, suggesting the device itself performed correctly once the test was properly executed.

2. Sample Size and Data Provenance

• Test Set Sample Size: The study involved a total of 90 tests for each analyte.
  • 3 testing locations
  • 6 operators (2 per facility)
  • 3 different lots of the control panel
  • Each operator performed 3 tests (1 per lot) on 5 different days.
  • Calculation: 3 (lots) * 5 (days) * 2 (operators/site) * 3 (sites) for each analyte = 90 tests per analyte.
• Data Provenance: The document does not explicitly state the country of origin. This was a prospective study conducted for the purpose of demonstrating performance for this 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Not applicable as this is a quality control material where the expected outcome (positive or negative for specific bacteria) is predetermined by the composition of the control. The "ground truth" is inherent to the control material itself (i.e., S. agalactiae is present in the positive control, L. acidophilus in the negative control).

4. Adjudication Method for the Test Set

Not applicable. The study measures agreement with the expected result of known positive and negative controls, not subjective interpretation requiring adjudication among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a study of a quality control material, not a diagnostic device that requires human interpretation. Therefore, there's no "human readers" to compare performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The study evaluated the performance of the Cepheid Xpert GBS LB Control Panel when used with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The results (100% agreement) demonstrate the device's ability to consistently produce the expected outcome.

7. Type of Ground Truth Used

The ground truth used is the known composition of the quality control materials. The positive control contains Streptococcus agalactiae (known to be detected by the assay as GBS positive), and the negative control contains Lactobacillus acidophilus (known not to be detected by the assay as GBS positive).

8. Sample Size for the Training Set

Not applicable. This device is a quality control material, not an AI/ML algorithm that requires a training set. Its performance is evaluated based on its consistency and accuracy in producing predetermined results when tested.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

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The BD MAX™ CT/GC/TV 20-Day QC Panel is intended for use as an external assayed positive quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis with the BD MAX™ CT/GC/TV Assay on the BD MAX™ System. The controls comprise cultured and inactivated C. trachomatis, N. qonorrhoeae and T. vaqinalis.

The BD MAX CT/GC/TV™ 20-Day QC Panel is not intended to replace manufacturer controls provided with the device.

The BD MAX™ CT/GC/TV 20-Day QC Panel is used to monitor the extraction, amplification and detection of the BD MAX™ CT/GC/TV Assay. The BD MAX™ CT/GC/TV 20-Day QC Panel contains authentic pathogens inactivated by radiological and temperature treatments. Each BD MAX™ CT/GC/TV 20-Day QC Panel consists of 20 individually packaged positive control pellets in a heat-sealed foil pouch. Each individually packaged pellet consists of inactivated Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis pathogens as well as preservatives and stabilized pellet containing inactivated organism(s) is packaged in a 2.0ml labeled micro-centrifuge tube with a red screw cap.

The document describes the BD MAX CT/GC/TV 20-Day QC Panel, an assayed quality control material for clinical microbiology assays. The provided information focuses on the device's performance in a precision and reproducibility study, which serves to demonstrate its functionality and reliability.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly demonstrated by the reported agreement percentages. While explicit "acceptance criteria" values (e.g., "must achieve >95% agreement") are not stated as such, the results show near-perfect agreement, suggesting these values implicitly meet the necessary performance for clearance.

Study Proving Device Meets Acceptance Criteria:

A "precision and reproducibility study" was conducted to demonstrate device performance.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: For each analyte (C. trachomatis, N. gonorrhoeae, T. vaginalis), a total of 90 tests were performed (30 tests at each of 3 sites).
  • This is calculated as: 3 sites * 2 operators/site * 3 lots tested/operator * 5 days/operator = 90 tests per analyte.
• Data Provenance: The study was conducted across three different testing locations. The exact countries are not specified, but the submission is to the U.S. FDA, implying the study was likely conducted in the US or in a manner compliant with US regulatory requirements. The study was prospective as it involved a planned experimental setup to test the device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device (quality control material for molecular assays) does not typically involve human expert interpretation of results to establish "ground truth" in the way an imaging AI algorithm would. For this device, the "ground truth" is the expected positive result based on the biological composition of the quality control material. The "experts" in this context would be the microbiologists and laboratory personnel who handle the molecular assays and interpret the objective quantitative or qualitative output from the BD MAX™ System. Their qualifications are inherent in their roles as laboratory operators capable of running and interpreting the BD MAX™ CT/GC/TV Assay.

4. Adjudication Method for the Test Set

Not applicable in the traditional sense for this device. The results are objective outputs from the BD MAX™ System (positive or negative detection). The document notes: "Three Unresolved results were obtained; in all cases a new control was retested and the expected results were obtained." This indicates a re-testing protocol for ambiguous results, but not an "adjudication" between conflicting human interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers are interpreting images or data. This device is a quality control material that produces objective results via a molecular diagnostic system. The study focused on the reproducibility of the device itself across different operators, sites, and lots.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, in essence, the performance study is a "standalone" evaluation of the quality control device's ability to consistently produce expected results when processed by the BD MAX™ CT/GC/TV Assay on the BD MAX™ System. The performance measured is the agreement of the QC panel with its known positive state when run on the automated system. Human operators initiate the test and record results, but their primary role is execution, not interpretation of a complex output requiring subjective judgment.

7. The Type of Ground Truth Used

The ground truth is based on the known composition of the quality control material. The BD MAX™ CT/GC/TV 20-Day QC Panel contains inactivated C. trachomatis, N. gonorrhoeae, and T. vaginalis pathogens. Therefore, the expected (ground truth) result for each test of the QC panel is "positive" for these analytes. The study explicitly states it "does not include a negative control," further confirming its intended use as a positive control.

8. The Sample Size for the Training Set

Not applicable. This device is a quality control material, not an AI/ML algorithm that requires a training set. Its "performance" is its ability to consistently yield a positive result when run on a specific molecular diagnostic system.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel are intended for use as external assayed positive quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Cryptosporidium parvum, Giardia lamblia, and Entamoeba histolytica performed with the BD MAX™ Enteric Parasite Panel on the BD MAX™ System. The controls comprise cultured and inactivated C. parvum, G. lamblia and recombinant Escherichia coli. The E. coli carries a plasmid which is a surrogate control material for detection of E. histolytica.

The BD MAX™ Enteric Parasite Control Panel and BD MAX™ Enteric Parasite 20-Day OC Panel are not intended to replace manufacturer controls provided with the device.

The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel are used to monitor the extraction, amplification of the BD MAX™ Enteric Parasite Panel. Both panels contain individually packaged pellets consisting of inactivated, Cryptosporidium parvum, Giardia lamblia, and a recombinant Escherichia coli. The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel differ only by packaged quantity. Each BD MAX™ Enteric Parasite Control Panel consists of 6 individually packaged positive control pellets. Each BD MAX™ Enteric Parasite 20-Day QC Panel consists of 20 individually packaged positive control pellet is individually wrapped with a desiccant in a heat-sealed foil pouch. The organisms are prepared in a buffered solution with materials of animal origin, preservatives and stabilizers. The solution is lyophilized into a ready-to-use pellet containing inactivated orqanism(s) is packaged in a 2.0-ml labeled micro-centrifuge tube with a red screw cap.

The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel do not contain negative controls.

Here's a breakdown of the acceptance criteria and study information for the BD MAX™ Enteric Parasite Control Panel and BD MAX™ Enteric Parasite 20-Day QC Panel, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" through numerical thresholds for precision and reproducibility in a tabular format. However, the study focuses on agreement for detecting the target analytes. Based on the results, the implied acceptance criterion is 100% agreement for the detection of each analyte.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set:
  • For each analyte (G. lamblia, E. histolytica, C. parvum): 90 tests total (30 tests per site x 3 sites).
  • The study involved testing 3 different lots of controls, by 6 different operators (2 per facility), over 5 days. Each operator performed 3 tests per day (1 per lot).
  • Calculations: 3 Lots x 6 Operators x 5 Days = 90 tests.
• Data Provenance: The document does not explicitly state the country of origin. It indicates "three different testing locations" were used, implying it was a multi-site study. It's a prospective study looking at the performance of the control panels.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For a quality control material, the "ground truth" is typically established by the known composition of the control material (i.e., it contains the specified inactivated organisms/recombinant E. coli). The study is evaluating if the device (BD MAX™ Enteric Parasite Panel on the BD MAX™ System) correctly detects these known components when the control is run.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of a quality control study for a qualitative detection assay, an "adjudication method" in the typical sense (e.g., for disagreements among human readers) is less applicable. The "results" are the output of the BD MAX™ System (detection or non-detection of the target analytes). The document notes retesting occurred for "Incomplete Run errors" and "Unresolved result," which serves as an internal resolution mechanism rather than an adjudication among independent interpreters.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically compares human reader performance (with and without AI assistance) on diagnostic images or complex cases. This document describes a performance study for a diagnostic quality control material, which does not involve human readers interpreting results in the same way.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance evaluation of the control panel with the BD MAX™ Enteric Parasite Panel and System was conducted. The study assesses the ability of the automated system to detect the known components within the control panel. While human operators initiate the tests, the performance reported (detection of G. lamblia, E. histolytica, C. parvum) is the output of the automated BD MAX™ system, without human interpretation influencing the final "positive" or "negative" call for the presence of the analytes.

7. The Type of Ground Truth Used

The ground truth used is the known composition of the control material. The control panels are manufactured to contain specific inactivated organisms (Cryptosporidium parvum, Giardia lamblia) and recombinant Escherichia coli (as a surrogate for E. histolytica). The "ground truth" is that these analytes are present in the control panels. The study verifies if the BD MAX™ System correctly identifies their presence.

8. The Sample Size for the Training Set

This information is not applicable/not provided for this specific document. This document describes the performance of a quality control material for a previously cleared diagnostic system (BD MAX™ Enteric Parasite Panel on the BD MAX™ System). Quality control materials themselves are not typically "trained" like AI algorithms. The underlying BD MAX™ system and its assays would have had their own development and validation, which might involve training data, but that is not the subject of this 510(k) for the control panels.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided (see point 8).

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